EN    EN EN 
SANCO/12561/2010 Rev. 2 (POOL/E4/2010/12561/12561R2-EN.doc)  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
refusing to authorise certain he alth claims made on foods, other than those referring to 
the reduction of disease risk and to  children's development and health  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
refusing to authorise certain he alth claims made on foods, other than those referring to 
the reduction of disease risk and to  children's development and health  
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the 
Council of 20 December 2006 on nutrition and health claims made on foods
1, and in 
particular Article 18(5) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/2006 hea lth claims made on food are prohibited 
unless they are authorised by the Commissi on in accordance with that Regulation and 
included in a list of permitted claims. 
(2) Regulation (EC) No 1924/2006 al so provides that applications for authorisations of 
health claims may be submitted by food business operators to the national competent 
authority of a Member State. The national competent authority is to forward valid 
applications to the Eu ropean Food Safety Authority (EFSA ), hereinafter referred to as 
the Authority.  
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Commission and to  deliver an opinion on a health claim 
concerned.  
(4) The Commission is to decide on the authorisa tion of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Gencor Pa cific Inc, submitted on 10 November 2009 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of ethanol-water 
extract of Caralluma fimbriata  (Slimaluma®) on helps to reduce waist circumference 
(Question No EFSA-Q-2010-00027)
2. The claim proposed by the applicant was 
worded, as follows: "Slimaluma® helps to reduce waist circumference".  
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2010; 8 (5):1602.  
EN 3   EN (6) On 12 May 2010 and on 18 May 2010, the Co mmission and the Member States 
received the scientific opinion from the Authority and its amendment respectively, 
which concluded that on the basis of the data submitted, a cause and effect relationship had not been established between the consum ption of Slimaluma® and the beneficial 
physiological effect as defined by th e Authority, namely, reduction of waist 
circumference leading to an improvement in adverse health effects associated with an 
excess abdominal fat. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(7) Following an application from Gencor Pa cific Inc, submitted on 10 November 2009 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of ethanol-water 
extract of Caralluma fimbriata  (Slimaluma®) on helps to reduce body fat (Question 
No EFSA-Q-2010-00028)
3. The claim proposed by the applicant was worded, as 
follows: "Slimaluma® helps to reduce body fat".  
(8) On 12 May 2010, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that on the basis of the data submitted, a cause and effect relationship had not been  established between the consumption of 
Slimaluma® and the claimed effect. Accordi ngly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(9) Following an application from Gencor Pa cific Inc, submitted on 10 November 2009 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of ethanol-water 
extract of Caralluma fimbriata  (Slimaluma®) on helps to reduce body weight 
(Question No EFSA-Q-2010-00029)
4. The claim proposed by the applicant was 
worded, as follows: "Slimaluma® helps to reduce body weight".  
(10) On 12 May 2010, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that on the basis of the data submitted, a cause and effect relationship had not been  established between the consumption of 
Slimaluma® and the claimed effect. Accordi ngly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(11) Following an application from Gencor Pa cific Inc, submitted on 10 November 2009 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of ethanol-water 
extract of Caralluma fimbriata  (Slimaluma®) on decreased energy intake (Question 
No EFSA-Q-2010-00030)
5. The claim proposed by the applicant was worded, as 
follows: "Slimaluma® helps to reduce caloric intake".  
(12) On 12 May 2010, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that on the basis of the data submitted, a cause and effect relationship had not been  established between the consumption of 
Slimaluma® and the claimed effect. Accordi ngly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
                                                
 
3 The EFSA Journal 2010; 8 (5):1602. 
4 The EFSA Journal 2010; 8 (5):1604. 
5 The EFSA Journal 2010; 8 (5):1605.  
EN 4   EN (13) Following an application from Gencor Pa cific Inc, submitted on 10 November 2009 
pursuant to Article 13(5 ) of Regulation (EC) No  1924/2006, the Authority was 
required to deliver an opinion on a health cl aim related to the effects of ethanol-water 
extract of Caralluma fimbriata (Slimaluma®) on helps to control hunger/appetite 
(Question No EFSA-Q-2010-00031)6. The claim proposed by the applicant was 
worded, as follows: "Slimaluma® he lps to control hunger/appetite".  
(14) On 12 May 2010, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that on the basis of the data submitted, a cause and effect relationship had not been  established between the consumption of 
Slimaluma® and the beneficial physiologi cal effect as defined by the Authority, 
namely, reduction of appetite leading to a reduction in subsequent energy intake. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(15) Following an application from Leiber GmbH, submitted on 2 October 2009 pursuant 
to Article 13(5) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim relate d to the effects of Yestimun® on immune 
responses (Question No EFSA-Q-2008-667)
7. The claim proposed by the ap plicant 
was worded, inter alia , as follows: "Daily administra tion of Yestimun® strengthens 
the body's defence during the cold season".  
(16) On 27 May 2010, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that on the basis of the data submitted, a cause and effect relationship had not been  established between the consumption of 
Yestimun® and the initiation of appropriate  innate and adaptive immune responses. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(17) Following an application from Laboratoires innéov SNC, submitted on 30 December 
2008 pursuant to Article 13(5) of Regulat ion (EC) No 1924/2006, the Authority was 
required to deliver an opinion on a health clai m related to the effects of blackcurrant 
seed oil ( Ribes nigrum ), fish oil, lycopene from tomato ( Lycopersicon esculentum ) 
extract, vitamin C and vitamin E on he lps to improve dry skin conditions (Question 
No EFSA-Q-2009-00767)
8. The claim proposed by the applicant was worded, inter 
alia, as follows: "Helps to improve dry skin condition".  
(18) On 25 May 2010, the Commission and the Member States received the scientific 
opinion from the Authority, which concluded that on the basis of the data submitted, a cause and effect relationship had not been  established between the intake of a 
combination of blackcurrant seed oil ( Ribes nigrum ), fish oil, lycopene from tomato 
(Lycopersicon esculentum ) extract, vitamin C and vitamin E and the claimed effect. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
                                                
 
6 The EFSA Journal 2010; 8 (5):1606. 
7 The EFSA Journal 2010; 8 (5):1607. 
8 The EFSA Journal 2010; 8 (5):1608.  
EN 5   EN (19) The comments from the applicants and the members of the public received by the 
Commission, pursuant to Article 16(6) of  Regulation (EC) No 1924/2006, have been 
considered when setting the measur es provided for in this Regulation. 
(20) The health claims related to Slimaluma® are h ealth claims as referred to in point (c) of 
Article 13(1) of Regulation (EC) No 1924/2006 and are therefore subject to the 
transition period laid down in Article 28( 6) of that Regulation. However, as the 
applications were not made before 19 Ja nuary 2008, the requirement provided for in 
point (b) of Article 28(6) of that Regulati on is not fulfilled, and therefore those claims 
may not benefit from the transition peri od provided for in that Article.  
(21) The health claims related to Yestim un®, and to blackcurrant seed oil ( Ribes nigrum ), 
fish oil, lycopene from tomato ( Lycopersicon esculentum ) extract, vitamin C and 
vitamin E, are health claims as referred to in point (a) of Article 13(1) of Regulation 
(EC) No 1924/2006 and are therefore subject to the transition period laid down in 
Article 28(5) of that Regulation. As the Au thority concluded that  cause and effect 
relationships have not been established be tween the foods and the respective claimed 
effects, the two claims do not comply  with Regulation (EC) No 1924/2006, and 
therefore they may not benefit from the transi tion period provided for in that Article. 
(22) In order to ensure that this Regulation is fully complied with, both food business 
operators and the national competent authorit ies should take the necessary actions to 
ensure that, at the latest six months follo wing the entry into force of this Regulation, 
products bearing the health claims listed in its Annex are no longer present on the 
market.  
(23) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them,   
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claims set out in the Annex to this Regulation shall not be included in the Union 
list of permitted claims as provided for in  Article 13(3) of Regulation (EC) No 1924/2006. 
However, products bearing these health claims placed on the market or labelled prior to the 
date referred to in Article 2 may remain on the market for a maximum period of six months 
after that date.  
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union .  
EN 6   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 7   EN ANNEX  
Rejected health claims  
Application – 
Relevant provisions of 
Regulation (EC) No 
1924/2006 Nutrient, 
substance, food or 
food category Claim EFSA 
opinion 
reference 
Article 13(5). Health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Ethanol-water 
extract of 
Caralluma 
fimbriata  
(Slimaluma®)  Slimaluma® helps to reduce 
waist circumference Q-2010-
00027 
Article 13(5). Health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Ethanol-water 
extract of 
Caralluma 
fimbriata  
(Slimaluma®)  Slimaluma® helps to reduce 
body fat Q-2010-
00028 
Article 13(5). Health claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Ethanol-water 
extract of 
Caralluma 
fimbriata  
(Slimaluma®)  Slimaluma® helps to reduce 
body weight Q-2010-
00029 
Article 13(5). Health 
claim based on newly developed scientific evidence and/or including a request for the protection of 
proprietary data Ethanol-water 
extract of 
Caralluma 
fimbriata  
(Slimaluma®)  Slimaluma® helps to reduce 
caloric intake Q-2010-
00030 
Article 13(5). Health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Ethanol-water 
extract of 
Caralluma 
fimbriata  
(Slimaluma®)  Slimaluma® helps to control 
hunger/appetite Q-2010-
00031  
EN 8   EN Article 13(5). Health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Yestimun® Daily administration of 
Yestimun® strengthens the 
body's defence during the cold 
season Q-2008-
667 
Article 13(5). Health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Combination of 
blackcurrant seed 
oil (Ribes nigrum ), 
fish oil, lycopene from tomato (Lycopersicon 
esculentum ) extract, 
vitamin C and 
vitamin E  Helps to improve dry skin 
condition Q-2009-
00767